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Efficacy and Safety Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Androgenetic Alopecia

This study is currently recruiting participants.
Verified July 2012 by Siriraj Hospital
Sponsor:
Information provided by (Responsible Party):
Rattapon Thuangtong, Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT01650272
First received: July 23, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5% Minoxidil in solution is the first choice preparation for treatment, therefore allergic contact dermatitis to solution was report up to 5.7% (Ebner H. et al,1995). Propylene glycol which is the main solvent of these solution, was the main responsible to allergic contact dermatitis with positive patch test up to 81.8% (Friedman ES. et al. 2002) One of the alternative solution using butylene glycol as the solvent was invented to solve the problem. In Siriraj hospital the investigators using this new solvent and made our in house product called 5% Minoxidil milky lotion. However the efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.


Condition Intervention Phase
Objective (Goal)
Self-Assessment
Adverse Effects
 Drug: 5% MInoxidil milky lotion
Drug: 5% Minoxidil solution
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Efficacy and Safety Pilot Study Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Treatment of AGA

Resource links provided by NLM:

Drug Information available for: Minoxidil
U.S. FDA Resources

Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:
  • Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution [ Time Frame: 6 month ] [ Designated as safety issue: No ]

    1. Target area hair evaluation

      • Hair density (Digital image, DinoLite pro)
      • Hair diameter (Electronic outside micrometer)
      • Hair count vellus/ non-vellus ratio
    2. Global photographic review (by 2 Experienced Dermatologist)
    3. Patient self evaluation ( 7point scale )


Secondary Outcome Measures:
  • Side effect of topical minoxidil [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    Record side effect such as Erythema, Dryness, Pruritus, Scaling, etc.


Other Outcome Measures:
  • Weight of topical minoxidil milky lotion / minoxidil lotion [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    Measure weight of topical minoxidil milky lotion / minoxidil lotion to confirm using of patient


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5%Minoxidil solution

This arm AGA patient receive 5%Minoxidil solution ( Propylene glycol solvent ) to use for 6 month.

Record efficacy and safety as described.

 Drug: 5% Minoxidil solution
Patient receive 5% Minoxidil solution (Propylene glycol solvent )
Other Names:
  • Minoxidil solution
  • Minoxidil lotion
Experimental: 5%Minoxidil milky lotion
This arm AGA patient receive 5%Minoxidil milky lotion to use for 6 month. Record efficacy and safety as described.
 Drug: 5% MInoxidil milky lotion
Patient receive 5% MInoxidil milky lotion (Butylene glycol solvent)
Other Names:
  • MInoxidil milky lotion
  • MInoxidil milk lotion

Detailed Description:

The 5% Minoxidil in solution is the first choice preparation for treatment for Androgenetic Alopecia (AGA), 5% Minoxidil milky lotion is the alternative solution using butylene glycol as the solvent to solve allergic contact dermatitis problem. In Siriraj hospital the investigators using this new solvent and made our in house product called he efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New case male AGA
  • Classification Norwood III vertex or IV

Exclusion Criteria:

  • Have previous AGA treatment in 6 month prior
  • Complicated case with other disease condition effect hair such as Anemia, DM, Chronic alcoholism, Autoimmune disease, Thyroid disease, previous GI surgery etc.
  • Other scalp lesion such as Psoriasis, Tinea capsitis
  • Psychological disorder including trichotillomania
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650272

Contacts
Contact: Rattapon Thuangtong, MD +662 4194333 rattaponthuangtong@yahoo.com
Contact: Kanchalit Thanomkitti, MD, PhD +668 95290298 kanchalitt@hotmail.com

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Kanchalit Thanomkitti, MD     +668 9529 0298     kanchalitt@hotmail.com    
Principal Investigator: Rattapon Thuangtong,, MD            
Sponsors and Collaborators
Siriraj Hospital
Investigators
Principal Investigator: Rattapon Thuangtong, MD Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
  More Information

Additional Information:
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Rattapon Thuangtong, Assistant Professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01650272     History of Changes
Other Study ID Numbers: SirirajH-006
Study First Received: July 23, 2012
Last Updated: July 25, 2012
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on May 22, 2013